Have You Considered the Potential of Deep Design?
How much time do medical product designers spend on understanding clinical processes?
Perhaps not enough.
Product designers “often don’t see their devices as part of a system,” says Kathleen Harder, PhD, director of the Center for Design in Health at the University of Minnesota. But there can be adverse ripple effects with devices, she warns.
Harder also serves as director of graduate studies in the Human Factors Program at University of Minnesota. For more than 15 years, she has worked with clinicians to test ideas that guide users toward desired behaviors in healthcare delivery. With a background as an experimental...
Source: MDDI - September 22, 2017 Category: Medical Devices Authors: Daphne Allen Tags: R & D Source Type: news
No change to alcohol guidelines for pregnancy
Conclusion
The results of this review found that low-to-moderate alcohol consumption during pregnancy was linked with a slightly increased risk of having a baby small for gestational age.
However, there was no evidence for any other links, including any difference in the average birth weight of babies born to drinkers and non-drinkers.
There are some important limitations of the research to note:
• The evidence still doesn't prove that drinking directly increases the risk of a baby born small for gestational age. Studies were observational and varied widely in accounting for the extensive number of confounding factors t...
Source: NHS News Feed - September 12, 2017 Category: Consumer Health News Tags: Pregnancy/child Source Type: news
Midpelvic Operative Vaginal Delivery Riskier Than Cesarean Midpelvic Operative Vaginal Delivery Riskier Than Cesarean
Midpelvic operative vaginal delivery is associated with significantly higher risk for severe birth trauma and obstetric trauma compared with cesarean delivery, a new study has found.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 9, 2017 Category: Consumer Health News Tags: Ob/Gyn & Women ' s Health News Source Type: news
Study finds forceps, vacuum deliveries more traumatic than c-sections
A study by the University of British Columbia shows midpelvic forceps and vacuum deliveries have higher rates of maternal, infant trauma compared to c-sections. (Source: Health News - UPI.com)
Source: Health News - UPI.com - June 5, 2017 Category: Consumer Health News Source Type: news
Midpelvic forceps, vacuum deliveries: Higher rates of trauma for mothers and babies
(Canadian Medical Association Journal) Compared with Cesarean deliveries, midpelvic forceps and midpelvic vacuum deliveries lead to higher rates of maternal and infant trauma, according to a new study published in Canadian Medical Association Journal. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 5, 2017 Category: International Medicine & Public Health Source Type: news
FDA releases June 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2016
TOTAL 510(k)s THIS PERIOD 258
TOTAL WITH SUMMARIES 235
TOTAL WITH STATEMENTS 23
DEVICE: ORAL BOND
STEINER LABORATORIES 510(k) NO: K142130(Traditional)
ATTN: GREGORY G STEINER PHONE NO : 866 3171348
1051 Olsen Street, Building 3611 SE DECISION MADE: 06-JUN-16
Henderson NV 89011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QiF Blood and Fluid Warmer
Quality in Flow Ltd. 510(k) NO: K150404(Traditional)
ATTN: Neta Sherman PHONE NO : 972 54 6600146
3A Bazel ...
Source: Mass Device - August 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Banning expert testimony from liability cases: Court decides
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Can trial courts block physicians ’ expert witnesses from testifying in medical liability cases? One Wisconsin court recently did, leaving it to the court of appeals to decide whether a physician defendant has the right to present expert testimony that differs from that of the plaintiffs. < /p > < p >
At stake in < em > Bayer v. Dobbins < /em > was whether trial court had properly excluded expert testimony regarding injuries to a newborn that had resulted in complications in the birthing process. < /p > < p > < strong > What happened in Wisconsin < /strong > < /p > < p >
Leah Bayer was delivering her chil...
Source: AMA Wire - July 22, 2016 Category: Journals (General) Authors: Troy Parks Source Type: news
Hair today; scalped tomorrow: massive subgaleal haematoma following sudden hair pulling in an adolescent in the absence of haematological abnormality or skull fracture - Edmondson SJ, Ramman S, Hachach-Haram N, Bisarya K, Fu B, Ong J, Akhavani M.
Subgaleal haematoma (SH) is a rare condition, most frequently observed in neonates as a complication of Ventouse-assisted delivery. There have been few patients reported beyond this period. Those that are present within the literature have typically result... (Source: SafetyLit)
Source: SafetyLit - June 7, 2016 Category: Global & Universal Tags: Age: Adolescents Source Type: news
Facial expressions are key to first impressions. What does that mean for people with facial paralysis?
This article was originally published on The Conversation. Read the original article. -- This feed and its contents are the property of The Huffington Post, and use is subject to our terms. It may be used for personal consumption, but may not be distributed on a website. (Source: Science - The Huffington Post)
Source: Science - The Huffington Post - May 30, 2016 Category: Science Source Type: news
Nigeria: Genital Assisted Device Will Reduce Deaths of Mothers - Experts
[Vanguard] Respite recently came on the way of pregnant mothers as a team of Nigerian medical doctors based in the Republic of Ireland introduced a hand-held vaginal assisted device to major public hospitals across the country. The device known as KIWI, produced by Clinical Innovation, United States of America is used to assist women who have difficulty delivering their babies. The device which is simple, light and mother and child friendly is said to work on the principle of vacuum delivery. (Source: AllAfrica News: Pregnancy and Childbirth)
Source: AllAfrica News: Pregnancy and Childbirth - March 4, 2016 Category: OBGYN Source Type: news
Essex woman's baby was born 'black and blue' after forceps delivery
GRAPHIC CONTENT Louise Greene, 19, from Essex, and her fiance Tommy Acott have revealed how Scarlett was born with a bruised scalp and a 6cm cut on her head after a complicated birth. (Source: the Mail online | Health)
Source: the Mail online | Health - February 5, 2016 Category: Consumer Health News Source Type: news
Where is best for birth: Hospital or home?
By the second half of the 20th century, hospital birth had become the norm in most Western countries. Hospital birth offers monitoring and interventions, many of which saved the lives of mothers and babies. At the same time, births became increasingly — and some would say unnecessarily — medicalized.
Many would also argue that the pendulum of intervention has swung too far. For example, from 1970 to 2010, the rate of U.S. cesarean delivery doubled — but (although both are low) the risk of a baby dying during the course of delivery remained unchanged, and the risk of a mother’s dying slightly rose. In an effort to a...
Source: New Harvard Health Information - January 14, 2016 Category: Consumer Health News Authors: Jeffrey Ecker, MD Tags: Family Planning and Pregnancy Health care Women's Health home births Source Type: news
How a Sunday of Service Could Change Your Life
Four weeks ago, my wife Leah and I welcomed our first child into the world (that's him in my arms in the picture above), but not without significant challenge for Leah. Leah was in labor for 49 hours -- never having a break of more than 12 minutes between contractions -- which culminated in 3.5 hours of pushing, and she accepted no pain medication. After 2.5 hours of pushing, the delivery team told Leah that they were worried she might not be able to get our son out without the help of forceps or suction. The team told Leah she had 30 minutes. If she couldn't get his head to crown in 30 minutes of pushing, they were go...
Source: Healthy Living - The Huffington Post - December 7, 2015 Category: Consumer Health News Source Type: news
Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015:
Summary of PMA Originals & Supplements Approved
Originals: 9
Supplements: 133
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 597
Total Active: 433
Total On Hold: 164
Summary of All PMA Submissions
Originals: 7
Supplements: 74
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 133
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 161.5
FDA Time: ...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Medtech approvals: FDA releases September 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015:
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 53
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 31
Total On Hold: 24
Summary of PMA Supplements Under Review
Total Under Review: 611
Total Active: 461
Total On Hold: 150
Summary of All PMA Submissions
Originals: 3
Supplements: 84
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 53
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 127.6
FDA Time: ...
Source: Mass Device - November 16, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
